National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

University of California, Davis

Other / NIH

Allocation: Randomized

Intervention Model: Crossover Assignment

Masking: None (Open Label)

Primary Purpose: Basic Science

Effect of SLC19A3 inhibitors on the absorption and distribution of thiamine as measured by the change in AUC between the thiamine and inhibitor (combination) arms and thiamine (single agent) arm.

Investigate metabolic signatures reflecting the activity of TPP-dependent enzymes by comparing levels of individual metabolites and metabolic ratios after the administration of thiamine or a combination of the thiamine and SLC19A3 inhibitor.

Effect of genetic variants of thiamine transporters on thiamine disposition and absorption.

Efficacy: Progression free survival (PFS1) according to modified Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) of Olaparib maintenance after a platinum based chemotherapy in patients with advanced or metastatic endometrial cancer

To determine Overall Survival (Time from randomization until death from any cause)

To determine time from randomization to efficacy by progression free survival

Phase Ib: Assessment of safety by identifying the Recommended Dose (RD) of the combination of Ramucirumab with Nabpaclitaxel and Gemcitabine.

Phase II: Overall Response Rate is defined as the proportion of patients with confirmed Complete Response or confirmed Partial Response as best overall response to treatment, based on RECIST v. 1.1 guidelines in the considered analysis population.

Number of patients with secondary cancers after diagnosis of Polycythemia Vera (PV), Essential Trombocythemia (ET) and Myelofibrosis (MF)

Number of patients with secondary cancers after diagnosis of Polycythemia Vera (PV), Essential Trombocythemia (ET) and Myelofibrosis (MF) in subgroups of subjects exposed to potential risk factors at diagnosis

Number of patients with secondary cancers after diagnosis of Polycythemia Vera (PV), Essential Trombocythemia (ET) and Myelofibrosis (MF) in the subgroups exposed to treatment

1881

All

Child, Adult, Older Adult

NCT03745378

MPN-K - FROM/O2- 2017

MPN-K

May 15, 2018

December 31, 2018

December 31, 2018

November 19, 2018

November 19, 2018

Palacky University and University Hospital Olomouc, Faculty of MedecineOlomouc, Czechia